Bente Glintborg1, Bjorn Gudbjornsson1, Niels Steen Krogh2, Emina Omerovic2, Natalia Manilo2, Mette Holland-Fischer2, Hanne M Lindegaard2, Anne Gitte Loft2, Henrik Nordin2, Laura Johnsen2, Sussi Flejsborg Oeftiger2, Annette Hansen2, Claus Rasmussen2, Gerdur Grondal2, Arni Jon Geirsson2, Merete Lund Hetland1. 1. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Danish Rheumatologic Database (DANBIO), Glostrup Hospital, Glostrup, Denmark, Center for Rheumatology Research (ICEBIO), Landspitali University Hospital of Iceland, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Zitelab Aps, Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Department of Rheumatology, Aalborg University Hospital, Aalborg, Department of Rheumatology, Odense University Hospital, Odense, Department of Rheumatology, Vejle Sygehus, Sygehus Lillebælt, Department of Infectious Diseases and Rheumatology, Rigshospitalet, Copenhagen, Department of Rheumatology, Helsingør and Hillerød Hospital, Hillerød, Department of Rheumatology, Køge Hospital, Køge, Department of Rheumatology, Gentofte University Hospital, Copenhagen, Department of Rheumatology, Vendsyssel Teaching Hospital, Hjørring, Denmark, Department of Rheumatology, Landspitali University Hospital of Iceland, Reykjavik, Iceland and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Danish Rheumatologic Database (DANBIO), Glostrup Hospital, Glostrup, Denmark, Center for Rheumatology Research (ICEBIO), Landspitali University Hospital of Iceland, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Zitelab Aps, Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Department of Rheumatology, Aalborg University Hospital, Aalborg, Department of Rheumatology, Odense University Hospital, Odense, Department of Rheumatology, Vejle Sygehus, Sygehus Lillebælt, Department of Infectious Diseases and Rheumatology, Rigshospitalet, Copenhagen, Department of Rheumatology, Helsingør and Hillerød Hospital, Hillerød, Department of Rheumatology, Køge Hospital, Køge, Department of Rheumatology, Gentofte University Hospital, 2. Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Danish Rheumatologic Database (DANBIO), Glostrup Hospital, Glostrup, Denmark, Center for Rheumatology Research (ICEBIO), Landspitali University Hospital of Iceland, Faculty of Medicine, University of Iceland, Reykjavik, Iceland, Zitelab Aps, Department of Rheumatology, Frederiksberg Hospital, Copenhagen, Department of Rheumatology, Aalborg University Hospital, Aalborg, Department of Rheumatology, Odense University Hospital, Odense, Department of Rheumatology, Vejle Sygehus, Sygehus Lillebælt, Department of Infectious Diseases and Rheumatology, Rigshospitalet, Copenhagen, Department of Rheumatology, Helsingør and Hillerød Hospital, Hillerød, Department of Rheumatology, Køge Hospital, Køge, Department of Rheumatology, Gentofte University Hospital, Copenhagen, Department of Rheumatology, Vendsyssel Teaching Hospital, Hjørring, Denmark, Department of Rheumatology, Landspitali University Hospital of Iceland, Reykjavik, Iceland and Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Abstract
OBJECTIVE: The aim of this study was to describe dose regimens, dose escalation and clinical outcomes in TNF-α inhibitor (TNFi)-naive patients with PsA treated withinfliximab in routine rheumatology care. METHODS: We conducted an observational cohort study based on the nationwide Danish Rheumatologic Database (DANBIO) and Center for Rheumatology Research (ICEBIO) registries. Stratified by country, characteristics of patients treated with ≤3 mg infliximab/kg body weight, 3-5 mg/kg or ≥5 mg/kg every 8 weeks were described. Outcomes were evaluated by ACR 20%, 50% and 70% (ACR20/50/70) responses and European League Against Rheumatism good response after 6 months, disease activity after 12 months, Kaplan-Meier plots and regression analyses. RESULTS:Four hundred and sixty-two patients (376 Danish, 86 Icelandic) received treatment withinfliximab. In Danish patients, the starting dose was ≤3 mg/kg in 110 patients (29%), 3-5 mg/kg in 157 (42%), ≥5 mg/kg in 38 (10%) and unregistered in 71 (19%). In Icelandic patients, corresponding numbers were 64 (74%), 17 (27%), 0 (0%) and 5 (6%). Patients with a higher body weight received lower doses per kilogram. Danish patients received higher doses than Icelandic patients at baseline [median 3.1 (interquartile range 3.0-3.8) vs 2.3 (2.1-2.9) mg/kg, P < 0.05] and after 12 months [3.3 (3.0-4.5) vs 2.9 (2.2-3.5) mg/kg, P < 0.0001]. After 12 months, 58% of Danish and 66% of Icelandic patients maintained treatment. Danish patients had shorter drug survival than Icelandic patients (1183 vs 483 days). In univariate analyses stratified by country, time until dose escalation, response rates, drug survival and 1-year's disease activity were independent of starting dose. Drug survival was shorter among patients not receiving concomitant MTX. CONCLUSION: In clinical practice, > 70% of Icelandic and Danish PsA patients treated with infliximab received sustained doses below the 5 mg/kg every 8 weeks recommended in international guidelines. Lower starting doses did not affect drug survival or response.
RCT Entities:
OBJECTIVE: The aim of this study was to describe dose regimens, dose escalation and clinical outcomes in TNF-α inhibitor (TNFi)-naive patients with PsA treated with infliximab in routine rheumatology care. METHODS: We conducted an observational cohort study based on the nationwide Danish Rheumatologic Database (DANBIO) and Center for Rheumatology Research (ICEBIO) registries. Stratified by country, characteristics of patients treated with ≤3 mg infliximab/kg body weight, 3-5 mg/kg or ≥5 mg/kg every 8 weeks were described. Outcomes were evaluated by ACR 20%, 50% and 70% (ACR20/50/70) responses and European League Against Rheumatism good response after 6 months, disease activity after 12 months, Kaplan-Meier plots and regression analyses. RESULTS: Four hundred and sixty-two patients (376 Danish, 86 Icelandic) received treatment with infliximab. In Danish patients, the starting dose was ≤3 mg/kg in 110 patients (29%), 3-5 mg/kg in 157 (42%), ≥5 mg/kg in 38 (10%) and unregistered in 71 (19%). In Icelandic patients, corresponding numbers were 64 (74%), 17 (27%), 0 (0%) and 5 (6%). Patients with a higher body weight received lower doses per kilogram. Danish patients received higher doses than Icelandic patients at baseline [median 3.1 (interquartile range 3.0-3.8) vs 2.3 (2.1-2.9) mg/kg, P < 0.05] and after 12 months [3.3 (3.0-4.5) vs 2.9 (2.2-3.5) mg/kg, P < 0.0001]. After 12 months, 58% of Danish and 66% of Icelandic patients maintained treatment. Danish patients had shorter drug survival than Icelandic patients (1183 vs 483 days). In univariate analyses stratified by country, time until dose escalation, response rates, drug survival and 1-year's disease activity were independent of starting dose. Drug survival was shorter among patients not receiving concomitant MTX. CONCLUSION: In clinical practice, > 70% of Icelandic and Danish PsA patients treated with infliximab received sustained doses below the 5 mg/kg every 8 weeks recommended in international guidelines. Lower starting doses did not affect drug survival or response.
Authors: Philip J Mease; Neil A Accortt; Sabrina Rebello; Carol J Etzel; Ryan W Harrison; Girish A Aras; Mahdi M F Gharaibeh; Jeffrey D Greenberg; David H Collier Journal: Rheumatol Int Date: 2019-07-18 Impact factor: 2.631
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Authors: Katerina Chatzidionysiou; Merete Lund Hetland; Thomas Frisell; Daniela Di Giuseppe; Karin Hellgren; Bente Glintborg; Dan Nordström; Kalle Aaltonen; Minna Rk Törmänen; Eirik Klami Kristianslund; Tore K Kvien; Sella A Provan; Bjorn Björn Guðbjörnsson; Lene Dreyer; Lars Erik Kristensen; Tanja Schjødt Jørgensen; Lennart Jacobsson; Johan Askling Journal: RMD Open Date: 2018-04-12
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